Malaysian Palm Oil Board, Persiaran Institusi, Bandar Baru Bangi, Kajang, Selangor Darul Ehsan, Malaysia.
Breast Cancer Res. 2010;12(5):R81. doi: 10.1186/bcr2726. Epub 2010 Oct 8.
Basic research has indicated that tocotrienols have potent antiproliferative and proapoptotic effects that would be expected to reduce the effect of breast cancer.
We conducted a double-blinded, placebo-controlled pilot trial to test the effectiveness of adjuvant tocotrienol therapy in combination with tamoxifen for five years in women with early breast cancer. Two-hundred-forty women, aged between 40-60 years, with either tumor node metastases (TNM) Stage I or II breast cancer and estrogen receptor (ER) positive tumors were non-randomly assigned to two groups. The intervention group received tocotrienol rich fraction (TRF) plus tamoxifen whilst the control group received placebo plus tamoxifen, for five years.
During the five years of study, 8 patients died due to breast cancer while 36 patients developed local or systemic recurrence. Five-year breast cancer specific survival was 98.3% (95% confidence interval (CI): 95.9% to 100%) in the intervention group and 95%, (95% CI: 91.1% to 98.9%) in the control group, while 5-years disease free survival was 86.7% (95% CI: 80.6% to 92.8%) and 83.3% (95% CI: 76.6% to 90.0%), respectively. Risk of mortality due to breast cancer was 60% (HR: 0.40; 95% CI: 0.08 to 2.05) lower in the intervention group versus the controls following adjustment for age, ethnicity, stage and lymph node status but this was not statistically significant. Adjuvant TRF therapy was not associated with breast cancer recurrence (HR: 0.84; 95% CI: 0.43-1.65).
From the current study, there seems to be no association between adjuvant tocotrienol therapy and breast cancer specific survival in women with early breast cancer.
ClinicalTrials.gov Identifier: NCT01157026.
基础研究表明，生育三烯酚具有很强的抗增殖和促凋亡作用，有望降低乳腺癌的影响。
我们进行了一项双盲、安慰剂对照的初步试验，以测试辅助生育三烯酚治疗与他莫昔芬联合使用五年对早期乳腺癌女性的疗效。240 名年龄在 40-60 岁之间的女性，患有肿瘤淋巴结转移（TNM）I 期或 II 期乳腺癌和雌激素受体（ER）阳性肿瘤，被非随机分为两组。干预组接受生育三烯酚丰富部分（TRF）加他莫昔芬治疗，而对照组接受安慰剂加他莫昔芬治疗，为期五年。
在五年的研究期间，8 名患者死于乳腺癌，36 名患者出现局部或全身复发。干预组五年乳腺癌特异性生存率为 98.3%（95%置信区间（CI）：95.9%至 100%），对照组为 95%（95%CI：91.1%至 98.9%），而 5 年无病生存率分别为 86.7%（95%CI：80.6%至 92.8%）和 83.3%（95%CI：76.6%至 90.0%）。调整年龄、种族、分期和淋巴结状态后，与对照组相比，干预组死于乳腺癌的风险降低了 60%（HR：0.40；95%CI：0.08 至 2.05），但无统计学意义。辅助 TRF 治疗与乳腺癌复发无关（HR：0.84；95%CI：0.43 至 1.65）。
从目前的研究来看，辅助生育三烯酚治疗与早期乳腺癌女性的乳腺癌特异性生存率之间似乎没有关联。
ClinicalTrials.gov 标识符：NCT01157026。
